Whether for cosmetic, aesthetic, or reconstructive purposes, soft tissue implants have become commonplace in today's society. Despite their growing popularity, a soft tissue implant can result, in some cases, in capsular contracture. Soon after an implant is placed into the body an inflammatory response begins to deposit collagen around the implant in the form of a fibrous capsule. In most cases for larger smooth implants the fibrous capsule is comprised of highly aligned and organized collagen fibers. As the fibrous capsule matures, certain events may trigger the differentiation of fibroblasts to a contractile phenotype, for example, myofibroblasts, and if the collagen fibers adjacent to the implant are aligned, capsular contracture ensues.
Capsular contracture can be debilitating to a patient because of discomfort or even pain, and can diminish the efficacy of the cosmetic or aesthetic results in both the look and feel of the implant.
Problems with capsular formation and contracture occur in many implant types such as pacemakers, dura mater substitutes, implantable cardiac defibrillators as well as breast and other esthetic implants. Implants with smooth surfaces in particular suffer most from capsular formation and contracture. Surface texturing has been shown to reduce capsular contracture when compared to common smooth surface implants when the implant is placed subglandularly.
Polyurethane textured coatings have been developed in an effort to reduce capsular formation and contracture. However, these coatings are biodegradable, and will therefore, lose any potential efficacy once the polyurethanes degrade. Also, some types of polyurethanes have been shown to degrade to potentially carcinogenic byproducts in vitro. Even further still, the manufacturing of polyurethane foam coated implants is increasingly complicated raising the cost of the resulting implant.
As such, there is a need in the art for textured implant coatings that reduce or even eliminate capsular formation and contracture. The present description fulfills this need in the art by providing coatings, implants including the coatings and methods of making and using the same.